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Bayer's Essure to Be Investigated

Bayer's Essure to Be Investigated
A citizen petition spurs an investigation of the permanent birth control device by CDRH’s Office of Compliance.

Marie Thibault

Roughly a month after receiving a citizen petition against Bayer’s Essure permanent birth control, FDA has forwarded the complaint to the Office of Compliance within Center for Devices and Radiological Health (CDRH) for investigation.

As previously reported, lawyers from the Law Office of Koch Parafinczuk & Wold, P.A. in Fort Lauderdale, FL, filed a citizen petition in late February against Essure permanent birth control. The authors represent hundreds of women who received Essure inserts and maintain that the device caused adverse events like device migration and organ perforation. The petitioners claim that medical data on Essure was fraudulently altered and that requirements of the device’s approval order and federal laws were flouted numerous times. The petition includes a request that FDA suspend Essure’s approval order and issue a recall.

The Essure system, now owned by Bayer after its 2013 acquisitions of Conceptus, involves hysteroscopic placement of nickel-titanium alloy inserts into the fallopian tubes, which, with tissue ingrowth, block the fallopian tubes and result in permanent birth control.

In a letter dated March 26 and posted online recently, William Maisel MD, MPH, deputy center director for science and chief scientist at CDRH, wrote that this petition is a “trade complaint because of the allegations against the ‘Essure’ product.”

The claims have been sent to the center’s Office of Compliance to be entered into the Allegation of Regulatory Misconduct system. The Office of Compliance will review and investigate the allegations and take action as needed. However, Maisel wrote, details of the investigation and explanation of the findings will not be communicated with the petitioners.

In an e-mailed statement, a Bayer spokesperson said, "The Citizen’s Petition regarding Essure was submitted to the FDA by a law firm that has filed several Essure product liability lawsuits naming Bayer as a defendant. The allegations made in the Citizen’s Petition are similar to those stated in the lawsuits. Bayer stands behind the safety and efficacy of Essure and will aggressively defend itself in Court. FDA has closed the petition and forwarded it to the Office of Compliance. We are cooperating with the FDA, and we will respond to any questions that the agency may have related to the allegations."

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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.

[Image courtesy of MASTER ISOLATED IMAGES/FREEDIGITALPHOTOS.NET]

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